Clincosm LogoSign in Get a demo

Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS

Sponsor
Aegerion Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00559962
Collaborator
(none)
260
Enrollment
15
Locations
8
Arms
13
Duration (Months)
17.3
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine safety and effectiveness of low-dose therapeutic AEGR-733 +/- atorvastatin, ezetimibe or fenofibrate (compared to placebo) on liver fat accumulation measured by Magnetic Resonance Spectroscopy

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

The goal within the current development program and this study is to investigate whether lower doses of AEGR-733 can result in significant reductions in LDL-C and TGs while providing fewer gastrointestinal adverse events and less hepatic fat accumulation than seen in studies with higher doses. The potential for atorvastatin, ezetimibe or the PPAR-alpha agonist (fenofibrate) to ameliorate any hepatic fat accumulation will also be investigated. The twelve week dosing schedule allows us to demonstrate the longer term effects of lower doses of MTP-I on hepatic fat accumulation.

Study Design

Study Type:
Interventional
Actual Enrollment :
260 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Low Doses of the MTP-Inhibitor AEGR-733 on Hepatic Fat Accumulation as Measured by Magnetic Resonance Spectroscopy
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 1

Placebo

Drug: placebo
3 capsules each evening for each 4-week period
Active Comparator: 2

2.5 mg AEGR-733

Drug: AEGR-733
3 capsules each evening for each 4-week period
Active Comparator: 3

5 mg AEGR-733

Drug: AEGR-733
3 capsules each evening for each 4-week period
Active Comparator: 4

7.5 mg AEGR-733

Drug: AEGR-733
3 capsules each evening for each 4-week period
Active Comparator: 5

10 mg AEGR-733

Drug: AEGR-733
3 capsules each evening for each 4-week period
Active Comparator: 6

5 mg AEGR-733 + 20 mg atorvastatin

Drug: AEGR-733 and atorvastatin
3 capsules each evening for each 4-week period
Active Comparator: 7

5 mg AEGR-733 + 145 mg fenofibrate

Drug: AEGR-733 and fenofibrate
3 capsules each evening for each 4-week period
Active Comparator: 8

5 mg AEGR-733 + 10 mg ezetimibe

Drug: AEGR-733 and ezetimibe
3 capsules each evening for each 4-week period

Outcome Measures

Primary Outcome Measures

  1. Absolute Change From Baseline in Percent Hepatic Fat [Baseline and 12 weeks on study drug]

    Absolute change from Baseline in percent hepatic fat

Secondary Outcome Measures

  1. Absolute Change From Baseline in Percent Hepatic Fat [Baseline and 12 weeks on study drug]

    Absolute change from Baseline in percent hepatic fat

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. LDL-C between 100 and 190 mg/dL

  2. Hepatic fat under 6.2% per MRS

Exclusion Criteria:

  1. Pregnant or lactating females

  2. Uncontrolled hypertension >180/95 mmHg

  3. Chronic renal insufficiency - serum creatinine >2.5 mg/dL at screen

  4. Liver disease; i.e., hepatitis, cirrhosis

  5. Major surgery within 3 months of screen

  6. Cardiac insufficiency

  7. Hx of malignancy other than basal or squamous cell within past 5 yrs

  8. Participation in any investigational drug study within 6 wks of screen

  9. Prior exposure to AEGR-733 in past 12 months

  10. Serious or unstable medical or psychological conditions

  11. More than one alcoholic drink per day

  12. Regular consumption of grapefruit juice or meds known to be metabolized by CYP 3A4

  13. Currently taking corticosteroids

  14. Other lipid-lowering meds (washout permitted)

  15. Fish oil, niacin grater than 200 mg/day and herbal weight loss products (washout permitted)

  16. Acute CVD or event within previous 6 months

  17. Diabetes Mellitus

  18. Hepatitis B or C

  19. Medicated COPD

  20. Idiopathic pulmonary fibrosis

  21. G.I. disorders that cause chronic diarrhea

  22. Fasting triglycerides =/> 400 mg/dL

  23. Body Mass Index > 35kg/m2

Contacts and Locations

Locations

Site City State Country Postal Code
1 Scripps Clinic San Diego California United States 92128
2 Radiant Research Santa Rosa California United States 95405
3 MedStar Research Institute Washington District of Columbia United States 20003
4 Radiant Research Chicago Illinois United States 60610
5 University of Iowa Iowa City Iowa United States 52242
6 LMARC Louisville Kentucky United States 40213
7 Maine Research Associates Auburn Maine United States 04210
8 Health Trends Research Baltimore Maryland United States 21209
9 Johns Hopkins Baltimore Maryland United States 21287
10 Washington Univ. School of Medicine Saint Louis Missouri United States 63110
11 Sterling Research Group Cincinnati Ohio United States 45219
12 University of Pennsylvania Philadelphia Pennsylvania United States 19104
13 Baylor College of Medicine Houston Texas United States 77030
14 Clinical Trial Network Houston Texas United States 77074
15 dgd Research San Antonio Texas United States 78229

Sponsors and Collaborators

  • Aegerion Pharmaceuticals, Inc.

Investigators

  • Study Director: William Sasiela, PhD, Aegerion Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00559962
Other Study ID Numbers:
  • AEGR-733-004
First Posted:
Nov 19, 2007
Last Update Posted:
Feb 23, 2018
Last Verified:
Feb 1, 2018
Keywords provided by , ,
LDL
hepatic fat
Additional relevant MeSH terms:
Hyperlipidemias
Atorvastatin
Ezetimibe
Fenofibrate

Study Results

Participant Flow

Recruitment Details The study was performed from 06 Sept 2007 to 05 Sept 2008. A total of 16 medical clinics participated in the study.
Pre-assignment Detail Subjects underwent a 5- to 9-week screening washout period to determine study eligibility and to wash-out patients of all lipid-lowering therapies; patients were required to have low-density lipoprotein cholesterol (LDL-C) between 100 and 190 mg/dL (average of 2 visits during screening) and hepatic fat less than 6.2% for randomization.
Arm/Group Title Placebo AEGR-733 2.5 mg AEGR-733 5 mg AEGR-733 7.5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 5 mg + Fenofibrate 145 mg AEGR-733 5 mg + Ezetimibe 10 mg
Arm/Group Description Oral placebo every 4 weeks for 12 weeks Oral lomitapide 2.5 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg every 4 weeks for 12 weeks Oral lomitapide 7.5 mg every 4 weeks for 12 weeks Oral lomitapide 10 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
Period Title: Overall Study
STARTED 33 34 34 34 35 28 33 29
COMPLETED 31 25 24 29 21 23 28 25
NOT COMPLETED 2 9 10 5 14 5 5 4

Baseline Characteristics

Arm/Group Title Placebo AEGR-733 2.5 mg AEGR-733 5 mg AEGR-733 7.5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 5 mg + Fenofibrate 145 mg AEGR-733 5 mg + Ezetimibe 10 mg Total
Arm/Group Description Oral placebo every 4 weeks for 12 weeks Oral lomitapide 2.5 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg every 4 weeks for 12 weeks Oral lomitapide 7.5 mg every 4 weeks for 12 weeks Oral lomitapide 10 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks Total of all reporting groups
Overall Participants 33 34 34 34 35 28 33 29 260
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
47.8
(12.53)
51.5
(12.99)
48.6
(11.3)
49.0
(10.24)
52.9
(11.97)
53.9
(8.92)
54.0
(11.95)
52.7
(9.36)
51.3
(11.44)
Sex: Female, Male (Count of Participants)
Female
19
57.6%
18
52.9%
16
47.1%
17
50%
20
57.1%
17
60.7%
17
51.5%
12
41.4%
136
52.3%
Male
14
42.4%
16
47.1%
18
52.9%
17
50%
15
42.9%
11
39.3%
16
48.5%
17
58.6%
124
47.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Asian
1
3%
0
0%
0
0%
1
2.9%
0
0%
0
0%
1
3%
0
0%
3
1.2%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Black or African American
5
15.2%
9
26.5%
8
23.5%
9
26.5%
8
22.9%
4
14.3%
7
21.2%
5
17.2%
55
21.2%
White
24
72.7%
21
61.8%
24
70.6%
23
67.6%
22
62.9%
22
78.6%
24
72.7%
22
75.9%
182
70%
More than one race
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
3
9.1%
4
11.8%
2
5.9%
1
2.9%
5
14.3%
2
7.1%
1
3%
2
6.9%
20
7.7%
Region of Enrollment (participants) [Number]
United States
33
100%
34
100%
34
100%
34
100%
35
100%
28
100%
33
100%
29
100%
260
100%

Outcome Measures

1. Primary Outcome
Title Absolute Change From Baseline in Percent Hepatic Fat
Description Absolute change from Baseline in percent hepatic fat
Time Frame Baseline and 12 weeks on study drug

Outcome Measure Data

Analysis Population Description
ITT
Arm/Group Title Placebo AEGR-733 5 mg
Arm/Group Description Oral placebo every 4 weeks for 12 weeks Oral lomitapide 5 mg every 4 weeks for 12 weeks
Measure Participants 31 24
Mean (Standard Deviation) [Percent of Hepatic Fat]
0.03
(1.814)
4.72
(6.297)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 5 mg
Comments One-way analysis of variance (ANOVA) to compare the absolute change from baseline to Week 12 in percent hepatic fat between AEGR-755 5 mg and placebo.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.68
Confidence Interval (2-Sided) 95%
2.30 to 7.07
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title Absolute Change From Baseline in Percent Hepatic Fat
Description Absolute change from Baseline in percent hepatic fat
Time Frame Baseline and 12 weeks on study drug

Outcome Measure Data

Analysis Population Description
ITT
Arm/Group Title Placebo AEGR-733 2.5 mg AEGR-733 5 mg AEGR-733 7.5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 5 mg + Fenofibrate 145 mg AEGR-733 5 mg + Ezetimibe 10 mg
Arm/Group Description Oral placebo every 4 weeks for 12 weeks Oral lomitapide 2.5 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg every 4 weeks for 12 weeks Oral lomitapide 7.5 mg every 4 weeks for 12 weeks Oral lomitapide 10 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
Measure Participants 31 27 24 27 20 23 26 26
Mean (Standard Deviation) [Percent of Hepatic Fat]
0.03
(1.814)
4.95
(7.122)
4.72
(6.297)
3.94
(5.763)
7.86
(9.515)
3.68
(5.365)
7.70
(9.390)
7.55
(6.230)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 5 mg
Comments One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments (All comparisons)
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.92
Confidence Interval (2-Sided) 95%
2.27 to 7.57
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 5 mg
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments (All comparisons)
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.68
Confidence Interval (2-Sided) 95%
2.30 to 7.07
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 7.5 mg
Comments One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments (All comparisons)
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.91
Confidence Interval (2-Sided) 95%
1.73 to 6.10
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 10 mg
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments (All comparisons)
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.82
Confidence Interval (2-Sided) 95%
4.31 to 11.33
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 5 mg + Atorvastatin 20 mg
Comments One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments (All comparisons)
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.65
Confidence Interval (2-Sided) 95%
1.58 to 5.72
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 5 mg + Fenofibrate 145 mg
Comments One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments (All comparisons)
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.66
Confidence Interval (2-Sided) 95%
4.22 to 11.11
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, AEGR-733 5 mg + Ezetimibe 10 mg
Comments One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments (All comparisons)
Method ANOVA
Comments
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.51
Confidence Interval (2-Sided) 95%
5.16 to 9.86
Parameter Dispersion Type:
Value:
Estimation Comments

Adverse Events

Time Frame From 10 days before the first dose to 30 days post last dose.
Adverse Event Reporting Description
Arm/Group Title Placebo AEGR-733 2.5 mg AEGR-733 5 mg AEGR-733 7.5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 5 mg + Fenofibrate 145 mg AEGR-733 5 mg + Ezetimibe 10 mg
Arm/Group Description Oral placebo every 4 weeks for 12 weeks Oral lomitapide 2.5 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg every 4 weeks for 12 weeks Oral lomitapide 7.5 mg every 4 weeks for 12 weeks Oral lomitapide 10 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
All Cause Mortality
Placebo AEGR-733 2.5 mg AEGR-733 5 mg AEGR-733 7.5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 5 mg + Fenofibrate 145 mg AEGR-733 5 mg + Ezetimibe 10 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Placebo AEGR-733 2.5 mg AEGR-733 5 mg AEGR-733 7.5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 5 mg + Fenofibrate 145 mg AEGR-733 5 mg + Ezetimibe 10 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/33 (0%) 1/34 (2.9%) 0/34 (0%) 0/34 (0%) 2/35 (5.7%) 0/28 (0%) 0/33 (0%) 0/29 (0%)
Gastrointestinal disorders
Inflammatory Bowel Disease 0/33 (0%) 0/34 (0%) 0/34 (0%) 0/34 (0%) 1/35 (2.9%) 0/28 (0%) 0/33 (0%) 0/29 (0%)
General disorders
Chest Pain 0/33 (0%) 1/34 (2.9%) 0/34 (0%) 0/34 (0%) 0/35 (0%) 0/28 (0%) 0/33 (0%) 0/29 (0%)
Injury, poisoning and procedural complications
Ankle Fracture 0/33 (0%) 0/34 (0%) 0/34 (0%) 0/34 (0%) 1/35 (2.9%) 0/28 (0%) 0/33 (0%) 0/29 (0%)
Other (Not Including Serious) Adverse Events
Placebo AEGR-733 2.5 mg AEGR-733 5 mg AEGR-733 7.5 mg AEGR-733 10 mg AEGR-733 5 mg + Atorvastatin 20 mg AEGR-733 5 mg + Fenofibrate 145 mg AEGR-733 5 mg + Ezetimibe 10 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 20/33 (60.6%) 31/34 (91.2%) 30/34 (88.2%) 29/34 (85.3%) 32/35 (91.4%) 24/28 (85.7%) 29/33 (87.9%) 25/29 (86.2%)
Gastrointestinal disorders
Diarrhoea 4/33 (12.1%) 16/34 (47.1%) 15/34 (44.1%) 16/34 (47.1%) 23/35 (65.7%) 14/28 (50%) 15/33 (45.5%) 19/29 (65.5%)
Nausea 1/33 (3%) 2/34 (5.9%) 8/34 (23.5%) 8/34 (23.5%) 13/35 (37.1%) 5/28 (17.9%) 8/33 (24.2%) 5/29 (17.2%)
Flatulence 2/33 (6.1%) 6/34 (17.6%) 3/34 (8.8%) 1/34 (2.9%) 2/35 (5.7%) 5/28 (17.9%) 1/33 (3%) 6/29 (20.7%)
Abdominal Pain Upper 2/33 (6.1%) 2/34 (5.9%) 2/34 (5.9%) 5/34 (14.7%) 4/35 (11.4%) 2/28 (7.1%) 2/33 (6.1%) 1/29 (3.4%)
Abdominal Distension 2/33 (6.1%) 2/34 (5.9%) 3/34 (8.8%) 4/34 (11.8%) 1/35 (2.9%) 2/28 (7.1%) 2/33 (6.1%) 2/29 (6.9%)
Vomiting 1/33 (3%) 2/34 (5.9%) 3/34 (8.8%) 1/34 (2.9%) 4/35 (11.4%) 2/28 (7.1%) 5/33 (15.2%) 0/29 (0%)
Dyspepsia 1/33 (3%) 4/34 (11.8%) 1/34 (2.9%) 1/34 (2.9%) 2/35 (5.7%) 2/28 (7.1%) 2/33 (6.1%) 4/29 (13.8%)
Constipation 3/33 (9.1%) 0/34 (0%) 0/34 (0%) 1/34 (2.9%) 0/35 (0%) 2/28 (7.1%) 4/33 (12.1%) 2/29 (6.9%)
Abdominal Pain 2/33 (6.1%) 2/34 (5.9%) 3/34 (8.8%) 1/34 (2.9%) 3/35 (8.6%) 1/28 (3.6%) 0/33 (0%) 0/29 (0%)
Abdominal Discomfort 0/33 (0%) 0/34 (0%) 1/34 (2.9%) 0/34 (0%) 2/35 (5.7%) 2/28 (7.1%) 1/33 (3%) 0/29 (0%)
Gastrointestinal Pain 0/33 (0%) 0/34 (0%) 0/34 (0%) 0/34 (0%) 0/35 (0%) 2/28 (7.1%) 1/33 (3%) 0/29 (0%)
Eruction 0/33 (0%) 0/34 (0%) 0/34 (0%) 0/34 (0%) 2/35 (5.7%) 0/28 (0%) 0/33 (0%) 0/29 (0%)
General disorders
Fatigue 2/33 (6.1%) 3/34 (8.8%) 5/34 (14.7%) 3/34 (8.8%) 3/35 (8.6%) 1/28 (3.6%) 3/33 (9.1%) 1/29 (3.4%)
Pyrexia 0/33 (0%) 0/34 (0%) 1/34 (2.9%) 0/34 (0%) 1/35 (2.9%) 2/28 (7.1%) 2/33 (6.1%) 0/29 (0%)
Influenza Like Illness 0/33 (0%) 0/34 (0%) 1/34 (2.9%) 0/34 (0%) 0/35 (0%) 0/28 (0%) 2/33 (6.1%) 0/29 (0%)
Immune system disorders
Seasonal Allergy 0/33 (0%) 0/34 (0%) 1/34 (2.9%) 2/34 (5.9%) 1/35 (2.9%) 0/28 (0%) 2/33 (6.1%) 0/29 (0%)
Infections and infestations
Upper Respiratory Tract Infection 1/33 (3%) 1/34 (2.9%) 0/34 (0%) 2/34 (5.9%) 0/35 (0%) 0/28 (0%) 4/33 (12.1%) 0/29 (0%)
Nasopharyngitis 1/33 (3%) 1/34 (2.9%) 0/34 (0%) 1/34 (2.9%) 1/35 (2.9%) 3/28 (10.7%) 0/33 (0%) 1/29 (3.4%)
Influenza 0/33 (0%) 1/34 (2.9%) 2/34 (5.9%) 0/34 (0%) 1/35 (2.9%) 0/28 (0%) 0/33 (0%) 2/29 (6.9%)
Investigations
Alanine Aminotransferase Increased 0/33 (0%) 3/34 (8.8%) 2/34 (5.9%) 1/34 (2.9%) 1/35 (2.9%) 0/28 (0%) 4/33 (12.1%) 0/29 (0%)
Aspartate Aminotransferase Increased 0/33 (0%) 2/34 (5.9%) 1/34 (2.9%) 1/34 (2.9%) 1/35 (2.9%) 0/28 (0%) 4/33 (12.1%) 0/29 (0%)
White Blood Cell Count Decreased 1/33 (3%) 2/34 (5.9%) 1/34 (2.9%) 0/34 (0%) 0/35 (0%) 0/28 (0%) 1/33 (3%) 0/29 (0%)
Protein Urine 0/33 (0%) 0/34 (0%) 2/34 (5.9%) 0/34 (0%) 1/35 (2.9%) 0/28 (0%) 0/33 (0%) 0/29 (0%)
C-reactive Protein 0/33 (0%) 0/34 (0%) 0/34 (0%) 0/34 (0%) 0/35 (0%) 2/28 (7.1%) 0/33 (0%) 0/29 (0%)
Metabolism and nutrition disorders
Decreased Appetite 0/33 (0%) 0/34 (0%) 0/34 (0%) 0/34 (0%) 2/35 (5.7%) 1/28 (3.6%) 1/33 (3%) 0/29 (0%)
Musculoskeletal and connective tissue disorders
Back Pain 2/33 (6.1%) 1/34 (2.9%) 2/34 (5.9%) 2/34 (5.9%) 1/35 (2.9%) 0/28 (0%) 1/33 (3%) 2/29 (6.9%)
Myalgia 0/33 (0%) 1/34 (2.9%) 2/34 (5.9%) 1/34 (2.9%) 0/35 (0%) 1/28 (3.6%) 1/33 (3%) 2/29 (6.9%)
Arthralgia 0/33 (0%) 0/34 (0%) 4/34 (11.8%) 0/34 (0%) 1/35 (2.9%) 0/28 (0%) 0/33 (0%) 2/29 (6.9%)
Musculoskeletal Pain 0/33 (0%) 0/34 (0%) 2/34 (5.9%) 0/34 (0%) 0/35 (0%) 0/28 (0%) 0/33 (0%) 0/29 (0%)
Nervous system disorders
Headache 4/33 (12.1%) 2/34 (5.9%) 6/34 (17.6%) 8/34 (23.5%) 1/35 (2.9%) 3/28 (10.7%) 4/33 (12.1%) 4/29 (13.8%)
Dizziness 1/33 (3%) 1/34 (2.9%) 2/34 (5.9%) 0/34 (0%) 1/35 (2.9%) 1/28 (3.6%) 0/33 (0%) 0/29 (0%)
Psychiatric disorders
Insomnia 3/33 (9.1%) 0/34 (0%) 2/34 (5.9%) 1/34 (2.9%) 0/35 (0%) 1/28 (3.6%) 0/33 (0%) 4/29 (13.8%)
Reproductive system and breast disorders
Dysmenorrhoea 0/33 (0%) 0/34 (0%) 2/34 (5.9%) 0/34 (0%) 0/35 (0%) 0/28 (0%) 0/33 (0%) 0/29 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 0/33 (0%) 2/34 (5.9%) 0/34 (0%) 1/34 (2.9%) 2/35 (5.7%) 0/28 (0%) 1/33 (3%) 2/29 (6.9%)
Oropharyngeal Pain 0/33 (0%) 1/34 (2.9%) 0/34 (0%) 1/34 (2.9%) 0/35 (0%) 0/28 (0%) 2/33 (6.1%) 0/29 (0%)
Skin and subcutaneous tissue disorders
Rash 0/33 (0%) 0/34 (0%) 0/34 (0%) 0/34 (0%) 0/35 (0%) 0/28 (0%) 3/33 (9.1%) 1/29 (3.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

PI can publish after sponsor reviews the proposed publication. PI must give sponsor at least 60 days to review before publication. PI needs to obtain sponsor's prior written consent to publish confidential information, which shall not be unreasonably withheld or delayed. The PI shall, upon request of sponsor, delete any confidential information which would prejudice the securing of adequate intellectual property protection from the publication.

Results Point of Contact

Name/Title Mark Sumeray, MD, Chief Medical Officer
Organization Aegerion Pharmaceuticals
Phone 617-500-7867
Email
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00559962
Other Study ID Numbers:
  • AEGR-733-004
First Posted:
Nov 19, 2007
Last Update Posted:
Feb 23, 2018
Last Verified:
Feb 1, 2018